Drug makers becoming wary of FDA
Published: March 26, 2008 at 11:52 PM
LONDON, March 26 (UPI) -- A Swiss drug maker says it may drop efforts to get U.S. approval for a new diabetes drug, despite the drug's popularity overseas.
The Wall Street Journal said Novartis AG may skip the U.S. market for the diabetes drug Galvus if the U.S. Food and Drug Administration makes the approval process too difficult.
The newspaper said some industry executives think the FDA faces more public and political pressure that the EU when considering new drugs. "The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," James Shannon of Novartis said. "I think it results in them taking decisions which are conservative."
Galvus was submitted in 2006 for approval in both the United States and Europe. While it has been approved in Europe, the FDA has postponed deciding on the drug on two occasions, the Journal said.
The Wall Street Journal said Novartis AG may skip the U.S. market for the diabetes drug Galvus if the U.S. Food and Drug Administration makes the approval process too difficult.
The newspaper said some industry executives think the FDA faces more public and political pressure that the EU when considering new drugs. "The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," James Shannon of Novartis said. "I think it results in them taking decisions which are conservative."
Galvus was submitted in 2006 for approval in both the United States and Europe. While it has been approved in Europe, the FDA has postponed deciding on the drug on two occasions, the Journal said.
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This material may not be reproduced, redistributed, or manipulated in any form.
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